Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - cobicistat, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - cobicistat, quantity: 150 mg; atazanavir, quantity: 300 mg - tablet, film coated - excipient ingredients: stearic acid; croscarmellose sodium; hyprolose; crospovidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide red - evotaz is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - darunavir ethanolate; cobicistat on silicon dioxide -

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg) - cobicistat 150 mg - adult patients: tybost is a cyp3a inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of hiv-1 infection in adults [see dosage and administration (2.1)]. pediatric patients: tybost is a cyp3a inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of hiv-1 infection in pediatric patients [see dosage and administration (2.2)]: - weighing at least 35 kg coadministered with atazanavir or - weighing at least 40 kg coadministered with darunavir. - tybost is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. the use of tybost is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir [see warnings and precautions (5.4)]. - complex or u

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg;  ;  ;   - film coated tablet - 150 mg - active: cobicistat 150mg       excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry orange 85f93642 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years or older.genotypic testing should guide the use of rezolsta.